Quality and Regulatory Affairs Lead

As a leader in 3D printing technology, Formlabs is reinventing the digital manufacturing industry. This mission takes innovation, persistence, and building the best team of people to make it happen. Join Formlabs if you want to bring groundbreaking professional 3D printers and materials to the desktop of medical and dental professionals all over the world.

Our Product and Manufacturing teams are looking for someone to help Formlabs products comply with regulatory standards as we develop new technologies and expand to markets across the globe. Are you excited to take a leadership role within the product lifecycle and put your regulatory, quality, and project management skills to work? If so, we want you to join us as our Quality and Regulatory Affairs Lead.

Experience with medical device development in an international work environment

Extensive experience in a comparable position in the healthcare industry, academia or scientific discipline

Focused, with the drive to set and stick to deadlines

Well-versed in manufacturing best practices

Solid understanding of current FDA practices in class I and class II categories

Bonus:

RAC certification

Interest in 3D printing

Our Perks:

Flexible Vacation

Generous premium coverage for medical, dental, and vision plans

Paid parental leave

Commuter benefits

Unlimited 3D prints

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Even if you don't check every box, but see yourself contributing, please apply. Help us build an inclusive community that will change the face of 3D printing.

About Formlabs

We’re a passionate team of engineers, designers, and problem-solvers. Started out of MIT in 2011, Formlabs now employs over 250 people across offices in Germany, Japan, and China. We're committed to bringing powerful and accessible fabrication tools into the creative hands of professionals around the world.
With the Form 2 SLA 3D printer, Fuse 1 SLS 3D printer, Form Cell manufacturing solution, and Pinshape marketplace of 3D designs, Formlabs is establishing the industry benchmark in professional 3D printing for professionals from a variety of industries. We also develop high-performance materials in-house, as well as best-in-class 3D printing software like PreForm and Dashboard.
We believe in what we do, and we’re excited about creating powerful tools that change the way we work and live.